CFDA approves China's first interventional artificial heart valve product

Recently, after review by the Food and Drug Administration, the registration of the innovative product “J-Valve Interventional Artificial Heart Valve” produced by Suzhou Jiecheng Medical Technology Co., Ltd. was approved.

CFDA批准我国首创介入人工生物心脏瓣膜产品上市

Established in September 2009, Suzhou Jiecheng Medical Technology Co., Ltd. is a minimally invasive medical technology company with complete independent intellectual property rights. The research and development team consists of Dr. Zhang Ji, a cardiac surgery expert, and a number of foreign senior professionals.

The product consists of a self-expanding interventional valve, a transapical interventional device, and a valve-loaded component. It is suitable for patients with autologous aortic valve disease who are considered unsuitable for surgery after evaluation by the cardiac team combined scoring system, including patients with aortic stenosis, and the main Patients with aortic regurgitation.

The product automatically locates the implantation site without rapid cardiac pacing, and the treatment for patients with aortic regurgitation is the first in China. The launch of the product will bring significant clinical benefits to patients with aortic stenosis and aortic regurgitation.

The food and drug supervision and administration department will strengthen the supervision of the product after listing and protect the safety of patients.

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